US20180207340A1 - Enhanced backflow prevention in a hemodialysis device - Google Patents
Enhanced backflow prevention in a hemodialysis device Download PDFInfo
- Publication number
- US20180207340A1 US20180207340A1 US15/411,606 US201715411606A US2018207340A1 US 20180207340 A1 US20180207340 A1 US 20180207340A1 US 201715411606 A US201715411606 A US 201715411606A US 2018207340 A1 US2018207340 A1 US 2018207340A1
- Authority
- US
- United States
- Prior art keywords
- valve
- hydrochamber
- recirculation
- water
- water inlet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/168—Sterilisation or cleaning before or after use
- A61M1/169—Sterilisation or cleaning before or after use using chemical substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/1629—Constructional aspects thereof with integral heat exchanger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1658—Degasification
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/168—Sterilisation or cleaning before or after use
- A61M1/1688—Sterilisation or cleaning before or after use with recirculation of the sterilising fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1694—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
Definitions
- the disclosure generally relates to a system and method for enhanced backflow prevention in a hemodialysis device, and more particularly to backflow prevention during a disinfectant operation in a hemodialysis device such as a chemical disinfection.
- Medical devices involving fluid flow typically include a fluid flow path for a disinfectant operation such as a chemical disinfection.
- a hemodialysis device can function in place of a kidney by filtering waste, salt, and fluid from a patient's blood when the patient's kidneys do not function properly.
- a chemical wash flows a disinfectant through the flow path. It is extremely critical that hemodialysis devices do not permit contamination of a chemical wash into a flow path containing fluid that may interact with a patient.
- a valve in a spent dialysate circuit is always closed, thereby preventing any potential contamination from the spent dialysate to the fresh water inlet. Additionally, an airgap between a water inlet valve and a hydrochamber prevents any patient contamination if there is an external loss of water pressure.
- a valve is opened so that a chemical disinfectant flows from the spent dialysate side to the hydrochamber.
- a drain valve opens at a periodic time interval to disinfect the drain line, and fresh water flows through the water inlet valve to replace the volume emptied out the drain valve.
- the water circuit is under positive pressure, so water flows into the water inlet valve, and disinfectant is prevented from backflowing through the water inlet valve.
- a hemodialysis system may comprise a hydrochamber adapted to heat and remove air from water and to provide backflow protection, a water circuit for water to flow from an external water source into the hydrochamber via a water inlet valve, a spent dialysate circuit for a disinfecting agent to flow to the hydrochamber via a recirculation valve during a disinfectant operation, and a drain valve disposed in the spent dialysate circuit.
- the hemodialysis system may be adapted to replace a volume of the disinfecting agent exiting the spent dialysate circuit via the drain valve with a substantially equal volume of water via the water inlet valve.
- the recirculation valve may be directly connected to the hydrochamber such that in response to a pressure drop at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- a method for preventing contamination in a hemodialysis device may comprise circulating water in a water circuit from an external water source to a hydrochamber via a water inlet valve, circulating a disinfecting agent in a spent dialysate circuit into the hydrochamber via a recirculation valve during a disinfectant operation, selectively opening a drain valve to flow a volume of the disinfecting agent through the drain valve out of the hemodialysis device, and selectively opening the water inlet valve to replace the volume of the disinfecting agent.
- the recirculation valve may be directly connected to the hydrochamber, such that in response to a pressure drop at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- a hemodialysis device for preventing backflow contamination during a loss of pressure at an external water source may comprise a water inlet valve in a water circuit for water to flow to a hydrochamber from the external water source, a recirculation valve in a fluid circuit for a disinfecting agent to flow to the hydrochamber during a disinfectant operation, a dual valve manifold, the dual valve manifold including a first channel with a first end port, and a second channel with a second end port, the first end port of the first valve line connecting to the water inlet valve, and the second end port of the second channel connecting to the recirculation valve.
- the first channel and the second channel may be separate channels in the dual valve manifold such that the flow paths are isolated.
- the recirculation valve may be directly connected to the hydrochamber, such that in response to the pressure loss at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- a method for preventing contamination in a hemodialysis device may comprise maintaining circulation of water in a water circuit from an external water source to a hydrochamber via a water inlet valve during a disinfectant operation, and isolating a flow of an agent from water in the water circuit leading to the external water source, such that in response to a pressure drop at the external water source, the agent is prevented from flowing into the external water source.
- FIG. 1 illustrates a schematic diagram of an existing hemodialysis device
- FIGS. 2A-2B illustrate a portion of the schematic diagram of FIG. 1 of an existing hemodialysis device
- FIG. 3 illustrates a portion of a schematic diagram of a hemodialysis device according to an embodiment of the present invention
- FIG. 4 illustrates a hydrochamber component of a hemodialysis device according to an embodiment of the present invention
- FIGS. 5A-5D illustrate a dual manifold valve of the hemodialysis device according to an embodiment of the present invention
- FIGS. 6A-6B illustrate a recirculation port of the hydrochamber of the hemodialysis device according to an embodiment of the present invention
- FIG. 7 illustrates a flow diagram of a method of preventing contamination in a hemodialysis device according to an embodiment of the present invention
- FIG. 8 illustrates a flow diagram of a method of preventing contamination in a hemodialysis device according to an embodiment of the present invention.
- FIGS. 1, 2A, and 2B a schematic diagram of an existing hemodialysis device is shown.
- FIGS. 2A and 2B show a portion 105 of the schematic diagram 100 illustrated in FIG. 1 .
- the hemodialysis device may include a hydrochamber 110 and a heat exchanger 115 in fluid communication with the hydrochamber 110 .
- a water circuit 120 and a spent dialysate circuit 125 in the hemodialysis device provide fluid flow in the portion 105 of the schematic diagram.
- An external water source (not shown) may provide water to the water circuit 120 .
- Water may flow through the heat exchanger 115 so that it is heated prior to entering the hydrochamber 110 .
- a water inlet valve 130 may be disposed in the water circuit between the heat exchanger 115 and the hydrochamber 110 . When the water inlet valve 130 is open, water may flow from the external water source into the hydrochamber 110 . In embodiments, water may flow past an air gap 145 in the hydrochamber. The air gap 145 may prevent potential backflow of the water from the hydrochamber back through the water inlet valve 130 .
- the hydrochamber 110 may include a plurality of chambers 110 A, 110 B, 110 C, 110 D, and 110 E.
- water may enter a first chamber, e.g., chamber 110 A and is heated in chamber 110 B.
- Control of the water flow may occur in chamber 110 C, for example, by including sensors and/or switches to monitor fluid in the hydrochamber.
- the fluid may be de-gassed or de-aerated in another chamber, e.g., 110 D and/or 110 E, so that balancing errors in the fluid are reduced.
- the fluid circuit is connected between the water inlet valve 130 , the recirculation valve 135 , and the hydrochamber 110 .
- a recirculation valve 135 remains closed, so that the spent dialysate circuit 125 remains closed off from the water circuit 120 . Potential patient contamination is thereby prevented should an external loss of water pressure occur.
- the highlighted flow line shows water flow from an external water source (not shown) through the heat exchanger 115 , through the water inlet valve 130 , and into the hydrochamber 110 past the air gap 145 . With the recirculation valve 135 closed, the water circuit 120 is isolated from the spent dialysate circuit 125 .
- one or more sensors 150 may be disposed in a chamber 110 A- 110 E.
- the sensor 150 may be a float to detect a fluid level in the hydrochamber 110 .
- a controller of the hemodialysis device may output a warning, alarm, and/or automatic shut-down.
- a disinfecting agent circulates from the spent dialysate circuit 125 to the hydrochamber 110 through the recirculation valve 135 .
- the disinfectant operation may be a chemical disinfection and/or rinse.
- the disinfecting agent may be a disinfectant. Periodic disinfection of the fluid circuits cleans the tubing in the system of microorganisms.
- a drain valve 140 may open at periodic time intervals to drain fluid out of the spent dialysate circuit, so that the disinfecting agent disinfects the drain valve 140 .
- the water inlet valve 130 opens to flow water in through the water circuit 120 .
- the water circuit 120 is kept at a positive pressure over the spent dialysate circuit 125 , so that water will always flow from a higher pressure area to the lower pressure hydrochamber when the water inlet valve 130 is opened.
- the water pressure may be 20 psi. However, if an external water source fails, the fluid pressure may drop in the water circuit 120 .
- the negative pressure in the water circuit 120 may result in a disinfecting agent back-flowing through the water inlet valve 130 .
- the highlighted flow path shows fluid in the spent dialysate circuit as well as the water circuit. Backflow occurs by the negative pressure at the external water source drawing the disinfecting agent through the water inlet valve 130 in a direction of arrow 155 shown in FIG. 2B , resulting in contamination of the inlet portion of the water circuit 120 and potentially the external water source itself. As described above, such contamination may put patients at serious risk.
- FIG. 3 a portion 300 of a schematic diagram of a hemodialysis device according to an embodiment of the present invention is shown.
- the recirculation valve 135 is directly connected to the hydrochamber 110 , so that a fluid flow path between the water inlet valve 130 and the recirculation valve 135 are independent of each other.
- a fluid flow path 160 may be between the water inlet valve 130 and the hydrochamber 110
- another, separate, fluid flow path 165 may be between the recirculation valve 135 and the hydrochamber 110 .
- the recirculation valve 135 is opened to flow a disinfecting agent from the spent dialysate circuit 125 to the hydrochamber 110 through the fluid flow path 165 .
- the drain valve 140 is opened at periodic time intervals, for example, every 30 seconds, a volume of fluid is drained. A disinfectant operation may last from 10 to 60 minutes.
- the drain valve 140 may be periodically opened while the disinfectant operation is ongoing, and may be pre-set, or pre-selected time intervals.
- the volume of fluid drained is replaced by substantially the same volume of flowing water through the water inlet valve 130 to the hydrochamber 110 , past the air gap 145 in the fluid flow path 160 . As described above, the air gap 145 prevents backflow of water from the hydrochamber 110 through the water inlet valve 130 .
- the hemodialysis device may include a fluid flow to the hydrochamber 110 from an external water source (not shown).
- the recirculation valve 135 may be directly connected to the hydrochamber 110 via tubing including a dual valve manifold 500 at the recirculation valve 135 and a recirculation port 600 at the hydrochamber 110 .
- the tubing may be connected to the hydrochamber 110 below the air gap 145 .
- the dual valve manifold 500 may be used to connect the recirculation valve 135 to the hydrochamber 110 , any configuration to individually connect the recirculation valve 135 to the hydrochamber 110 and the water inlet valve 130 to the hydrochamber 110 is envisioned.
- the dual valve manifold 500 may include a first channel 505 with a first end port 510 and a first valve connection 515 , and a second channel 520 with a second end port 525 and a second valve connection 530 .
- the first end port 510 of the first channel 505 may connect to the water inlet valve 130 , and the first valve connection 515 of the first channel 505 may be connected to the hydrochamber 110 , or vice versa.
- the second end port 525 of the second channel 520 may connect to the recirculation valve 135 and the second valve connection 530 of the second channel 520 may connect to the hydrochamber 110 , or vice versa.
- the first and second channels 505 , 520 may be formed in an “L” shape, with the dual valve manifold 500 being a rectangular shape, although any configurations that provide for independent and/or isolated flow paths between the water inlet valve 130 and the hydrochamber 110 , on the one hand, and recirculation valve 135 and hydrochamber 110 , on the other hand, are suitable.
- the dual valve manifold 500 may be formed of a plastic material, for example, polyethersulfone, to withstand corrosive fluids in the hemodialysis device.
- tubing 535 may be connected to ports 510 , 525 .
- the tubing may be secured by a fastener 540 , such as a clip or clamp to secure the tubing to the ports 510 , 525 .
- the ports 510 , 525 may be configured to fit within tubing, attached so that leaks are prevented.
- the first channel 505 and the second channel 520 may separate, independent flow paths to the hydrochamber, which are isolated by the configuration of the dual valve manifold 500 .
- FIG. 5D which is a sectional view of FIG. 5C
- the dual valve manifold 500 provides for two paths to connect to the hydrochamber 110 .
- a recirculation port 600 may be disposed at the hydrochamber 110 .
- the recirculation port 600 may include a connecting end 605 for tubing (not shown) to be attached.
- a flow path 610 through the recirculation port 600 allows for fluid to flow to the hydrochamber 110 through the tubing and the dual valve manifold 500 from the recirculation valve 135 .
- a connecting end 615 is configured to join the recirculation port 600 to the hydrochamber 110 .
- a seal for example, a ring seal, may be disposed between the hydrochamber 110 and the recirculation port 600 to prevent leakage.
- an additional connector 620 may attach the recirculation port 600 to the hydrochamber 110 .
- additional connector 620 may be a hole to receive a screw, bolt, rivet, or other mechanical fastener.
- the recirculation port 600 may be cylindrical or circular in shape. In an embodiment, the recirculation port 600 may be any shape permitting a fluid flow path 610 .
- the recirculation port 600 may be formed of a plastic material, for example, polyethersulfone, to withstand corrosive fluids in the hemodialysis device.
- a flow diagram 700 of a method of preventing backflow in a hemodialysis device is shown.
- the hemodialysis device circulates water in a water circuit from an external water source to a hydrochamber via a water inlet valve.
- the hemodialysis device circulates a disinfecting agent in a spent dialysate circuit into the hydrochamber via a recirculation valve during a disinfectant operation.
- the hemodialysis device selectively opens a drain valve to flow a volume of the disinfecting agent through the drain valve out of the hemodialysis device.
- the hemodialysis device selectively opens the water inlet valve to replace the volume of the disinfecting agent.
- the recirculation valve is directly connected to the hydrochamber, such that in response to a pressure drop at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- a flow diagram 800 of a method of preventing backflow in a hemodialysis device is shown.
- the hemodialysis device maintains circulation of water in a water circuit from an external water source to a hydrochamber via a water inlet valve during a disinfectant operation.
- the hemodialysis device isolates a flow of an agent from water in the water circuit leading to the external water source, such that in response to a pressure drop at the external water source, the agent is prevented from flowing into the external water source.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- External Artificial Organs (AREA)
Abstract
Description
- The disclosure generally relates to a system and method for enhanced backflow prevention in a hemodialysis device, and more particularly to backflow prevention during a disinfectant operation in a hemodialysis device such as a chemical disinfection.
- Medical devices involving fluid flow typically include a fluid flow path for a disinfectant operation such as a chemical disinfection. A hemodialysis device can function in place of a kidney by filtering waste, salt, and fluid from a patient's blood when the patient's kidneys do not function properly. To ensure the flow paths are properly disinfected for patient use, a chemical wash flows a disinfectant through the flow path. It is extremely critical that hemodialysis devices do not permit contamination of a chemical wash into a flow path containing fluid that may interact with a patient.
- During a dialysis operation, a valve in a spent dialysate circuit is always closed, thereby preventing any potential contamination from the spent dialysate to the fresh water inlet. Additionally, an airgap between a water inlet valve and a hydrochamber prevents any patient contamination if there is an external loss of water pressure.
- During a chemical disinfection operation, a valve is opened so that a chemical disinfectant flows from the spent dialysate side to the hydrochamber. A drain valve opens at a periodic time interval to disinfect the drain line, and fresh water flows through the water inlet valve to replace the volume emptied out the drain valve. During normal operation, the water circuit is under positive pressure, so water flows into the water inlet valve, and disinfectant is prevented from backflowing through the water inlet valve.
- If an external water source fails, the water is no longer under positive pressure, and the chemical disinfectant has a path for potential backflow through the water inlet valve. Although risk to the patient is remote, a solution is needed to prevent potential backflow contamination to ensure patient safety.
- It is with respect to these and other considerations that the present improvements may be useful.
- This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.
- In an embodiment, a hemodialysis system may comprise a hydrochamber adapted to heat and remove air from water and to provide backflow protection, a water circuit for water to flow from an external water source into the hydrochamber via a water inlet valve, a spent dialysate circuit for a disinfecting agent to flow to the hydrochamber via a recirculation valve during a disinfectant operation, and a drain valve disposed in the spent dialysate circuit. During the disinfectant operation, the hemodialysis system may be adapted to replace a volume of the disinfecting agent exiting the spent dialysate circuit via the drain valve with a substantially equal volume of water via the water inlet valve. The recirculation valve may be directly connected to the hydrochamber such that in response to a pressure drop at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- In an embodiment, a method for preventing contamination in a hemodialysis device may comprise circulating water in a water circuit from an external water source to a hydrochamber via a water inlet valve, circulating a disinfecting agent in a spent dialysate circuit into the hydrochamber via a recirculation valve during a disinfectant operation, selectively opening a drain valve to flow a volume of the disinfecting agent through the drain valve out of the hemodialysis device, and selectively opening the water inlet valve to replace the volume of the disinfecting agent. The recirculation valve may be directly connected to the hydrochamber, such that in response to a pressure drop at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- In an embodiment, a hemodialysis device for preventing backflow contamination during a loss of pressure at an external water source may comprise a water inlet valve in a water circuit for water to flow to a hydrochamber from the external water source, a recirculation valve in a fluid circuit for a disinfecting agent to flow to the hydrochamber during a disinfectant operation, a dual valve manifold, the dual valve manifold including a first channel with a first end port, and a second channel with a second end port, the first end port of the first valve line connecting to the water inlet valve, and the second end port of the second channel connecting to the recirculation valve. The first channel and the second channel may be separate channels in the dual valve manifold such that the flow paths are isolated. The recirculation valve may be directly connected to the hydrochamber, such that in response to the pressure loss at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve.
- In an embodiment, a method for preventing contamination in a hemodialysis device may comprise maintaining circulation of water in a water circuit from an external water source to a hydrochamber via a water inlet valve during a disinfectant operation, and isolating a flow of an agent from water in the water circuit leading to the external water source, such that in response to a pressure drop at the external water source, the agent is prevented from flowing into the external water source.
- By way of example, specific embodiments of the disclosed device will now be described, with reference to the accompanying drawings, in which:
-
FIG. 1 illustrates a schematic diagram of an existing hemodialysis device; -
FIGS. 2A-2B illustrate a portion of the schematic diagram ofFIG. 1 of an existing hemodialysis device; -
FIG. 3 illustrates a portion of a schematic diagram of a hemodialysis device according to an embodiment of the present invention; -
FIG. 4 illustrates a hydrochamber component of a hemodialysis device according to an embodiment of the present invention; -
FIGS. 5A-5D illustrate a dual manifold valve of the hemodialysis device according to an embodiment of the present invention; -
FIGS. 6A-6B illustrate a recirculation port of the hydrochamber of the hemodialysis device according to an embodiment of the present invention; -
FIG. 7 illustrates a flow diagram of a method of preventing contamination in a hemodialysis device according to an embodiment of the present invention; -
FIG. 8 illustrates a flow diagram of a method of preventing contamination in a hemodialysis device according to an embodiment of the present invention. - The present embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which several exemplary embodiments are shown. The subject matter of the present disclosure, however, may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and willfully convey the scope of the subject matter to those skilled in the art. In the drawings, like numbers refer to like elements throughout.
- Referring to
FIGS. 1, 2A, and 2B , a schematic diagram of an existing hemodialysis device is shown.FIGS. 2A and 2B show aportion 105 of the schematic diagram 100 illustrated inFIG. 1 . - The hemodialysis device may include a
hydrochamber 110 and aheat exchanger 115 in fluid communication with thehydrochamber 110. Awater circuit 120 and a spentdialysate circuit 125 in the hemodialysis device provide fluid flow in theportion 105 of the schematic diagram. An external water source (not shown) may provide water to thewater circuit 120. Water may flow through theheat exchanger 115 so that it is heated prior to entering thehydrochamber 110. Awater inlet valve 130 may be disposed in the water circuit between theheat exchanger 115 and thehydrochamber 110. When thewater inlet valve 130 is open, water may flow from the external water source into thehydrochamber 110. In embodiments, water may flow past anair gap 145 in the hydrochamber. Theair gap 145 may prevent potential backflow of the water from the hydrochamber back through thewater inlet valve 130. - The
hydrochamber 110 may include a plurality of chambers 110A, 110B, 110C, 110D, and 110E. In an embodiment, water may enter a first chamber, e.g., chamber 110A and is heated in chamber 110B. Control of the water flow may occur in chamber 110C, for example, by including sensors and/or switches to monitor fluid in the hydrochamber. The fluid may be de-gassed or de-aerated in another chamber, e.g., 110D and/or 110E, so that balancing errors in the fluid are reduced. The fluid circuit is connected between thewater inlet valve 130, therecirculation valve 135, and thehydrochamber 110. - As described above, during a dialysis operation or dialysis mode, backflow of fluid is prevented by the air gap between the
water inlet valve 130 and thehydrochamber 110. Additionally, arecirculation valve 135 remains closed, so that thespent dialysate circuit 125 remains closed off from thewater circuit 120. Potential patient contamination is thereby prevented should an external loss of water pressure occur. As shown inFIG. 2A , the highlighted flow line shows water flow from an external water source (not shown) through theheat exchanger 115, through thewater inlet valve 130, and into thehydrochamber 110 past theair gap 145. With therecirculation valve 135 closed, thewater circuit 120 is isolated from the spentdialysate circuit 125. To detect a loss of water pressure, as described above, one ormore sensors 150 may be disposed in a chamber 110A-110E. In an embodiment, thesensor 150 may be a float to detect a fluid level in thehydrochamber 110. In response to a change in the fluid level in thehydrochamber 110, a controller of the hemodialysis device may output a warning, alarm, and/or automatic shut-down. - During a disinfectant operation, a disinfecting agent circulates from the spent
dialysate circuit 125 to thehydrochamber 110 through therecirculation valve 135. In an embodiment, the disinfectant operation may be a chemical disinfection and/or rinse. In an embodiment, the disinfecting agent may be a disinfectant. Periodic disinfection of the fluid circuits cleans the tubing in the system of microorganisms. - A
drain valve 140 may open at periodic time intervals to drain fluid out of the spent dialysate circuit, so that the disinfecting agent disinfects thedrain valve 140. To replace the drained fluid volume, thewater inlet valve 130 opens to flow water in through thewater circuit 120. Thewater circuit 120 is kept at a positive pressure over the spentdialysate circuit 125, so that water will always flow from a higher pressure area to the lower pressure hydrochamber when thewater inlet valve 130 is opened. For example, the water pressure may be 20 psi. However, if an external water source fails, the fluid pressure may drop in thewater circuit 120. Thus, when thewater inlet valve 130 is opened at the same time therecirculation valve 135 is opened during the disinfectant operation, the negative pressure in thewater circuit 120 may result in a disinfecting agent back-flowing through thewater inlet valve 130. As shown inFIG. 2B , the highlighted flow path shows fluid in the spent dialysate circuit as well as the water circuit. Backflow occurs by the negative pressure at the external water source drawing the disinfecting agent through thewater inlet valve 130 in a direction ofarrow 155 shown inFIG. 2B , resulting in contamination of the inlet portion of thewater circuit 120 and potentially the external water source itself. As described above, such contamination may put patients at serious risk. - Referring now to
FIG. 3 , aportion 300 of a schematic diagram of a hemodialysis device according to an embodiment of the present invention is shown. Therecirculation valve 135 is directly connected to thehydrochamber 110, so that a fluid flow path between thewater inlet valve 130 and therecirculation valve 135 are independent of each other. For example, in an embodiment, afluid flow path 160 may be between thewater inlet valve 130 and thehydrochamber 110, and another, separate,fluid flow path 165 may be between therecirculation valve 135 and thehydrochamber 110. - During a disinfectant operation, the
recirculation valve 135 is opened to flow a disinfecting agent from the spentdialysate circuit 125 to thehydrochamber 110 through thefluid flow path 165. When thedrain valve 140 is opened at periodic time intervals, for example, every 30 seconds, a volume of fluid is drained. A disinfectant operation may last from 10 to 60 minutes. Thedrain valve 140 may be periodically opened while the disinfectant operation is ongoing, and may be pre-set, or pre-selected time intervals. The volume of fluid drained is replaced by substantially the same volume of flowing water through thewater inlet valve 130 to thehydrochamber 110, past theair gap 145 in thefluid flow path 160. As described above, theair gap 145 prevents backflow of water from thehydrochamber 110 through thewater inlet valve 130. - In the event of a loss of pressure at an external water source when the
recirculation valve 135 is open during a disinfectant operation, disinfecting agent is prevented from flowing back through thewater inlet valve 130 due to the independentfluid flow paths - Referring now to
FIGS. 4, 5A-5D, and 6A-6B , ahydrochamber 110 and components of a hemodialysis device according to an embodiment of the present invention are shown. As described above, the hemodialysis device may include a fluid flow to thehydrochamber 110 from an external water source (not shown). Therecirculation valve 135 may be directly connected to thehydrochamber 110 via tubing including adual valve manifold 500 at therecirculation valve 135 and arecirculation port 600 at thehydrochamber 110. In some embodiments, the tubing may be connected to thehydrochamber 110 below theair gap 145. Although thedual valve manifold 500 may be used to connect therecirculation valve 135 to thehydrochamber 110, any configuration to individually connect therecirculation valve 135 to thehydrochamber 110 and thewater inlet valve 130 to thehydrochamber 110 is envisioned. - The
dual valve manifold 500 may include afirst channel 505 with afirst end port 510 and afirst valve connection 515, and asecond channel 520 with asecond end port 525 and asecond valve connection 530. Thefirst end port 510 of thefirst channel 505 may connect to thewater inlet valve 130, and thefirst valve connection 515 of thefirst channel 505 may be connected to thehydrochamber 110, or vice versa. Thesecond end port 525 of thesecond channel 520 may connect to therecirculation valve 135 and thesecond valve connection 530 of thesecond channel 520 may connect to thehydrochamber 110, or vice versa. The first andsecond channels dual valve manifold 500 being a rectangular shape, although any configurations that provide for independent and/or isolated flow paths between thewater inlet valve 130 and thehydrochamber 110, on the one hand, andrecirculation valve 135 andhydrochamber 110, on the other hand, are suitable. Thedual valve manifold 500 may be formed of a plastic material, for example, polyethersulfone, to withstand corrosive fluids in the hemodialysis device. - As shown in
FIGS. 5A and 5B ,tubing 535 may be connected toports fastener 540, such as a clip or clamp to secure the tubing to theports ports first channel 505 and thesecond channel 520 may separate, independent flow paths to the hydrochamber, which are isolated by the configuration of thedual valve manifold 500. As more clearly shown inFIG. 5D , which is a sectional view ofFIG. 5C , thedual valve manifold 500 provides for two paths to connect to thehydrochamber 110. - Referring now to
FIGS. 6A, 6B , arecirculation port 600 may be disposed at thehydrochamber 110. Therecirculation port 600 may include a connectingend 605 for tubing (not shown) to be attached. Aflow path 610 through therecirculation port 600 allows for fluid to flow to thehydrochamber 110 through the tubing and thedual valve manifold 500 from therecirculation valve 135. A connectingend 615 is configured to join therecirculation port 600 to thehydrochamber 110. In an embodiment, a seal, for example, a ring seal, may be disposed between thehydrochamber 110 and therecirculation port 600 to prevent leakage. In an embodiment, anadditional connector 620 may attach therecirculation port 600 to thehydrochamber 110. For example,additional connector 620 may be a hole to receive a screw, bolt, rivet, or other mechanical fastener. - The
recirculation port 600 may be cylindrical or circular in shape. In an embodiment, therecirculation port 600 may be any shape permitting afluid flow path 610. Therecirculation port 600 may be formed of a plastic material, for example, polyethersulfone, to withstand corrosive fluids in the hemodialysis device. - Referring now to
FIG. 7 , a flow diagram 700 of a method of preventing backflow in a hemodialysis device according to an embodiment of the present invention is shown. Instep 705, the hemodialysis device circulates water in a water circuit from an external water source to a hydrochamber via a water inlet valve. Atstep 710, the hemodialysis device circulates a disinfecting agent in a spent dialysate circuit into the hydrochamber via a recirculation valve during a disinfectant operation. Atstep 715, the hemodialysis device selectively opens a drain valve to flow a volume of the disinfecting agent through the drain valve out of the hemodialysis device. Atstep 720, the hemodialysis device selectively opens the water inlet valve to replace the volume of the disinfecting agent. The recirculation valve is directly connected to the hydrochamber, such that in response to a pressure drop at the external water source, the disinfecting agent is prevented from back-flowing through the water inlet valve. - Referring now to
FIG. 8 , a flow diagram 800 of a method of preventing backflow in a hemodialysis device according to an embodiment of the present invention is shown. Atstep 805, the hemodialysis device maintains circulation of water in a water circuit from an external water source to a hydrochamber via a water inlet valve during a disinfectant operation. Atstep 810, the hemodialysis device isolates a flow of an agent from water in the water circuit leading to the external water source, such that in response to a pressure drop at the external water source, the agent is prevented from flowing into the external water source. - As used herein, an element or operation recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or operations, unless such exclusion is explicitly recited. Furthermore, references to “one embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.
- The present disclosure is not to be limited in scope by the specific embodiments described herein. Indeed, other various embodiments of and modifications to the present disclosure, in addition to those described herein, will be apparent to those of ordinary skill in the art from the foregoing description and accompanying drawings. Thus, such other embodiments and modifications are intended to fall within the scope of the present disclosure. Furthermore, although the present disclosure has been described herein in the context of a particular implementation in a particular environment for a particular purpose, those of ordinary skill in the art will recognize that its usefulness is not limited thereto and that the present disclosure may be beneficially implemented in any number of environments for any number of purposes.
- Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the present disclosure as described herein.
Claims (27)
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/411,606 US10426881B2 (en) | 2017-01-20 | 2017-01-20 | Enhanced backflow prevention in a hemodialysis device |
PCT/US2018/014497 WO2018136781A1 (en) | 2017-01-20 | 2018-01-19 | Enhanced backflow prevention in a hemodialysis device |
AU2018210389A AU2018210389B2 (en) | 2017-01-20 | 2018-01-19 | Enhanced backflow prevention in a hemodialysis device |
CA3046245A CA3046245C (en) | 2017-01-20 | 2018-01-19 | Enhanced backflow prevention in a hemodialysis device |
CN201880007459.0A CN110191730B (en) | 2017-01-20 | 2018-01-19 | Enhanced backflow prevention in hemodialysis devices |
EP18713062.0A EP3570904B1 (en) | 2017-01-20 | 2018-01-19 | Enhanced backflow prevention in a hemodialysis device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/411,606 US10426881B2 (en) | 2017-01-20 | 2017-01-20 | Enhanced backflow prevention in a hemodialysis device |
Publications (2)
Publication Number | Publication Date |
---|---|
US20180207340A1 true US20180207340A1 (en) | 2018-07-26 |
US10426881B2 US10426881B2 (en) | 2019-10-01 |
Family
ID=61764113
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/411,606 Active 2037-08-02 US10426881B2 (en) | 2017-01-20 | 2017-01-20 | Enhanced backflow prevention in a hemodialysis device |
Country Status (6)
Country | Link |
---|---|
US (1) | US10426881B2 (en) |
EP (1) | EP3570904B1 (en) |
CN (1) | CN110191730B (en) |
AU (1) | AU2018210389B2 (en) |
CA (1) | CA3046245C (en) |
WO (1) | WO2018136781A1 (en) |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20140174698A1 (en) * | 2012-12-24 | 2014-06-26 | B. Braun Avitum Ag | Blood purification machine comprising heated fluid circuit |
US20160356874A1 (en) * | 2015-06-02 | 2016-12-08 | Fresenius Medical Care Holdings, Inc. | Sensor Calibration for Dialysis Systems |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA1090261A (en) | 1976-05-21 | 1980-11-25 | Dean Hardy | Cleaner for dialyzers |
SE401893B (en) | 1976-10-14 | 1978-06-05 | Gambro Ab | DIALYSIS SYSTEM |
US4773991A (en) | 1987-03-13 | 1988-09-27 | Baxter Travenol Laboratories, Inc. | Water purification system fluid path |
US5247434A (en) * | 1991-04-19 | 1993-09-21 | Althin Medical, Inc. | Method and apparatus for kidney dialysis |
DE4440556A1 (en) | 1994-11-12 | 1996-05-15 | Polaschegg Hans Dietrich Dr | Device and method for determining the amount of uremia toxins removed during hemodialysis treatment |
US20030034305A1 (en) | 2001-01-05 | 2003-02-20 | Gambro, Inc. | Purified water supply system for high demand devices and applications |
KR102228428B1 (en) * | 2007-02-27 | 2021-03-16 | 데카 프로덕츠 리미티드 파트너쉽 | Hemodialysis system |
WO2008146068A1 (en) | 2007-05-25 | 2008-12-04 | Gambro Lundia Ab | A device for connecting to a liquid source |
CN101829371B (en) * | 2010-05-20 | 2011-10-05 | 重庆山外山科技有限公司 | Hemodialysis system |
US8834718B2 (en) | 2010-07-09 | 2014-09-16 | Wd Manor Mechanical Contractors, Inc. | Dialysis service box |
US9861733B2 (en) | 2012-03-23 | 2018-01-09 | Nxstage Medical Inc. | Peritoneal dialysis systems, devices, and methods |
CN103977465B (en) * | 2014-01-27 | 2016-01-27 | 南昌大学第二附属医院 | A kind of implantating biological artificial kidney device |
-
2017
- 2017-01-20 US US15/411,606 patent/US10426881B2/en active Active
-
2018
- 2018-01-19 WO PCT/US2018/014497 patent/WO2018136781A1/en unknown
- 2018-01-19 EP EP18713062.0A patent/EP3570904B1/en active Active
- 2018-01-19 AU AU2018210389A patent/AU2018210389B2/en active Active
- 2018-01-19 CN CN201880007459.0A patent/CN110191730B/en active Active
- 2018-01-19 CA CA3046245A patent/CA3046245C/en active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20140174698A1 (en) * | 2012-12-24 | 2014-06-26 | B. Braun Avitum Ag | Blood purification machine comprising heated fluid circuit |
US20160356874A1 (en) * | 2015-06-02 | 2016-12-08 | Fresenius Medical Care Holdings, Inc. | Sensor Calibration for Dialysis Systems |
Also Published As
Publication number | Publication date |
---|---|
CN110191730A (en) | 2019-08-30 |
AU2018210389B2 (en) | 2020-04-09 |
CA3046245C (en) | 2021-04-06 |
CN110191730B (en) | 2022-04-29 |
CA3046245A1 (en) | 2018-07-26 |
AU2018210389A1 (en) | 2019-06-13 |
EP3570904A1 (en) | 2019-11-27 |
EP3570904B1 (en) | 2022-03-16 |
WO2018136781A1 (en) | 2018-07-26 |
US10426881B2 (en) | 2019-10-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP2737915B1 (en) | Dialysate extraction device | |
JP5748280B2 (en) | Dialysate extraction device | |
JP5369140B2 (en) | Mixing equipment | |
CN105903097B (en) | Connector for dialyser | |
JP5813403B2 (en) | Dialysate extraction device | |
US11590454B2 (en) | System of detecting a leak in a heat exchanger of a hemodialysis device | |
EP1660138B1 (en) | Filter assembly for a reprocessor | |
US10426881B2 (en) | Enhanced backflow prevention in a hemodialysis device | |
US8821719B2 (en) | Arrangement for connection of a medical device to a water line | |
US7419645B2 (en) | Disinfecting and cleaning agent connection device | |
JP7223359B2 (en) | Port device, purified water production device including port device and method for port cleaning of purified water production device | |
KR102171036B1 (en) | Device for performing a method for conserving a blood treatment device and method for conserving a blood treatment device | |
CN114127019B (en) | Dialysis system with stationary water preparation unit | |
JP2014210067A (en) | Branch port | |
JP2018094368A (en) | Method for detecting leakage of transducer protector of blood purification device |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: FRESENIUS MEDICAL CARE HOLDINGS, INC., MASSACHUSET Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CRNKOVICH, MARTY;LEVIN, ROLAND;WANG, FEI;REEL/FRAME:041152/0545 Effective date: 20170125 |
|
AS | Assignment |
Owner name: FRESENIUS MEDICAL CARE HOLDINGS, INC., MASSACHUSET Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CRNKOVICH, MARTY;LEVIN, ROLAND;WANG, FEI;REEL/FRAME:043900/0518 Effective date: 20171016 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NOTICE OF ALLOWANCE MAILED -- APPLICATION RECEIVED IN OFFICE OF PUBLICATIONS |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: PUBLICATIONS -- ISSUE FEE PAYMENT VERIFIED |
|
STCF | Information on status: patent grant |
Free format text: PATENTED CASE |
|
MAFP | Maintenance fee payment |
Free format text: PAYMENT OF MAINTENANCE FEE, 4TH YEAR, LARGE ENTITY (ORIGINAL EVENT CODE: M1551); ENTITY STATUS OF PATENT OWNER: LARGE ENTITY Year of fee payment: 4 |